1) Technical Field
This invention relates to the art of grafting hair follicles from one area of the dermis to another, wherein the tissue bearing the hair follicles may be obtained, for example, from the occipital scalp using a specialized knife. More particularly, it relates to a tool useful in modifying raw follicle-bearing dermal sections in order to maximize the relative population of successful follicle transplantations, as well as a method for using the tool.
2) Description of Related Art
The well-known phenomenon of male pattern baldness has provided a great deal of motivation for improvements in techniques for transplanting hair follicles from one area of the body to a scalp region in which functional follicles are no longer active. Typically, hair is harvested from the back or side of the scalp to create hair grafts which are subsequently implanted in the front, top, and crown of the head. Several workers in this field have provided a wide variety of devices and methods aimed at improved graft harvesting and placement techniques, including the disclosures of U.S. Pat. Nos. 5,693,064; 5,643,308; 5,611,811; 5,611,810; 5,584,851; 5,584,841; 5,578,054; 5,562,732; 5,490,850; 5,439,475; 5,417,683; 5,273,900; and 4,243,038, the entire contents of which are herein incorporated by reference thereto.
Although there have been several advances made in recent years with regards to increasing the density of transplanted follicles and the aesthetic appeal of the configurations employed, young men undergoing hair restoration surgery may still be disappointed for several reasons, including poor graft growth, inflammation, (folliculitis), which, although typically treatable by conventional antibiotics, has in recent years been encountered in resistive strains. Additionally, transplanted hair often also kinks and curls unpredictably.
Poor graft growth is an unpredictable complication of hair transplant surgery and has been reported with every technique ever employed including round grafts, minigrafts, micrografts, strip grafts, 1-hair, and 2-hair grafts. The complication of poor graft growth is the least understood complication of this type of surgery and occurs even with the most meticulous technique in the hands of skilled surgeons.
A critical aspect of successful transplant surgery is the quality of the grafts produced. Quality is dependent on several factors including hair characteristics (i.e., color, texture, waviness) hair density, and the technique by which the grafts are produced. Of these, the characteristics and density are variables beyond the control of the surgeon. Thus the key factor in performing a successful hair transplant is the graft production technique.
Micrografts of the scalp ("donor strips") are regularly obtained from rectangular, elongated strips of occipital donor scalp containing hair follicles measuring up to about 20 cm in length and 1.0 to 2.0 mm wide and about 5 mm in depth. Donor strips are typically harvested from the occipital scalp using a specialized knife well-known to those of ordinary skill in this art to be comprised of a handle bearing at its end up to eleven parallel cutting blades spaced equidistant from each other at about 1 to 2 mm. Through use of such a knife, graft strips measuring about 1.5 mm in width and 12-16 cm in length may be obtained.
Surgeons typically harvest several parallel donor strips simultaneously. Following the harvest, technicians section the donor strips, manually, by laying the strips on a hard, flat surface and making cuts perpendicular to the overall length of the strip. Such cuts are made parallel to the direction of growth of hair from the individual follicles and are spaced such that each cut section contains between about 1 and 6 root follicles. Sections of the graft strips so obtained are subsequently implanted by surgical technique in a region of the scalp where hair loss had been encountered. Although such manual sectioning and transplanting is labor intensive whereby the costs of the manipulations passed on to the patient, the results are considered to justify the expenditure in most cases.
Accordingly, it is seen that contemporary hair transplant technique has evolved into the use of larger numbers of small grafts. To reap the benefits associated therewith, many hair transplant surgeons have gone to using micrografts, as set forth above, exclusively, to obtain natural-appearing results in shortened time frames. This has in turn resulted in an increased demand placed on the surgical team to create and place typically over one thousand grafts per patient, which is substantially greater than that of even the recent past. Accordingly, the per worker output for transplant technicians is significantly decreased by surgeons desirous of employing this most-preferred technique.
An advance in the field of transplant technology was brought forth recently by the invention of Pascal Boudjema, as described in U.S. Pat. No. 5,662,661; the contents of which are herein incorporated by reference. The '661 patent describes a device containing a plurality of equally-spaced, parallel blades having their cutting edges coincide along a common plane. In its operation, a graft strip is laid across the blades, and a clamping means is caused to slowly apply a uniform force to the graft along its entire length. The result of this undertaking is that the labor associated with the step in which perpendicular cuts are made on the graft strips mentioned above may now be carried out in a single operation, rather than in a series of individual incisions. Obviously, the number of cuts which a given technician can carry out using this method and apparatus is substantially increased over the prior method.
However, the device and process of the '661 patent is not without a major drawback, that being the damage caused to the graft strips as a result of the squeezing force applied to the graft strips in accordance with the disclosed process for which that device was intended. The application of the steadily-increasing, force relied upon by the Boudjema art for the cutting operation tends to cause crushing and distortion of the tissues within and immediately surrounding individual hair follicles, and is believed to contribute materially to the failure of a significant number of transplanted follicles to produce healthy hair following transplantation. Clearly, it would be desirable to provide a device and method which provide the increased technician capacity of the '661 patent, while at the same time producing grafts which are not damaged or distorted by the crushing forces required thereby, so as to produce a larger number of healthier grafts than are available using any other method or apparatus, including manually cut grafts. It is towards the solution of this, and the other aforementioned problems in the art that the device and process of the instant invention is directed.
Therefore, it is an object of this invention to provide a novel technique by which hair grafts having an increased graft growth rate over all prior art in this field may be produced. It is yet another object of this invention to provide a device useful in the novel technique of this invention by which transplant technician productivity may be substantially increased, particularly where larger numbers of smaller grafts are employed, without damaging the individual grafts by, for example, crushing forces.